Temporary vascular filter

ABSTRACT

The present invention provides a method of deploying a medical filter within a channel in a patient&#39;s body and filter systems which can be used in such a method. Such a filter may include a radially expandable body  52  having an opening  56  in a proximal length thereof. In one method, the filter is urged along a length of the channel with the filter body in a radially reduced configuration. This body is expanded to substantially fill the lumen of the vessel and orient the opening in the body proximally. Body fluid is permitted to enter the filter body through the proximally oriented opening and pass distally through the distal length of the body so that the distal length of the body filters from the body fluid particulate material entrained therein. The proximal length of the body can be drawn into the retrieval catheter, thereby effectively closing the proximally oriented opening within the catheter to retain the particulate material within the enclosure. In a preferred embodiment, the filter body  52  is formed of a porous, resilient fabric having pores therein and the proximal opening  56  is at least five times the size of such pores.

This application is a continuation of application Ser. No. 11/842,316,filed Aug. 21, 2007, which is a continuation of application Ser. No.11/517,222, filed Sep. 7, 2006, which is a continuation of applicationSer. No. 10/682,696, filed Oct. 9, 2003, which is a continuation ofapplication Ser. No. 09/824,910, filed Apr. 3, 2001, now abandoned,which is a continuation of application Ser. No. 09/400,159, filed Sep.21, 1999, now U.S. Pat. No. 6,325,815 B1, issued Dec. 4, 2001, thecontents of each of which are hereby incorporated herein by reference.

FIELD OF THE INVENTION

The present invention generally relates to filters for body passageways,and has particular utility in connection with temporary vascularfilters.

BACKGROUND OF THE INVENTION

Filters can be deployed in channels or vessels in patient's bodies in avariety of medical procedures or in treating certain conditions. Forexample, rotating burrs are used in removing atheroma from the lumen ofpatients' blood vessels. These burrs can effectively dislodge theatheroma, but the dislodged material will simply float downstream withthe flow of blood through the vessel. Filters can be used to capturesuch dislodged material before it is allowed to drift too fardownstream, possibly occluding blood flow through a more narrow vessel.

Some researchers have proposed various traps or filters for capturingthe particulate matter released or created in such procedures. However,most such filters generally have not proven to be exceptionallyeffective in actual use. These filters tend to be cumbersome to use andaccurate deployment is problematic because if they are not properlyseated in the vessel they can drift to a more distal site where they arelikely to do more harm than good. In addition, these filters aregenerally capable of only trapping relatively large thrombi and are noteffective for removing smaller embolic particles from the blood stream.

The problems with most temporary filters, which are intended to be usedonly during a particular procedure then retracted with the thrombitrapped therein, are more pronounced. Even if the trap does effectivelycapture the dislodged material, it has proven to be relatively difficultor complex to retract the trap back into the catheter through which itwas delivered without simply dumping the trapped thrombi back into theblood stream, defeating the purpose of the temporary filter device. Forthis reason, most atherectomy devices and the like tend to aspirate thepatient's blood during the procedure to remove the dislodged materialentrained therein.

One promising filter design which overcomes many of these difficultiesis shown in International Publication No. WO 96/01591 (the publicationof PCT International Application No. PCT/US95/08613), the teachings ofwhich are incorporated herein by reference. Generally, this referenceteaches a trap which can be used to filter particles from blood or otherfluid moving through a body vessel. In one illustrated embodiment, thistrap includes a basket 270 which can be deployed and retracted through acatheter or the like, making it particularly suitable for use inminimally invasive procedures such as angioplasty or atherectomyprocedures. The fact that this trap is optimally carried on a mandrel260 further enhances its utility as most common angioplasty balloons andatherectomy devices are used in conjunction with such mandrels. Whilethis trap is very useful and shows great promise in many commonprocedures, it may be possible to better retain the thrombi collected inthe filter during retrieval of the filter.

SUMMARY OF THE INVENTION

The present invention provides a method of deploying a medical filterwithin a channel in a patient's body and devices which are well suitedfor use in such procedures. In accordance with one method of theinvention, a filter and retrieval catheter are provided. This filter hasa radially expandable body having proximal and distal ends and whichdefines an enclosure. The expandable body has a distal length and aproximal length which includes an opening therein. The retrievalcatheter has a lumen with a diameter less than the maximum dimension ofthe body's expanded configuration. This filter is urged along a lengthof the channel in the patient's body with the filter body in a radiallyreduced configuration. The body is radially expanded to its expandedconfiguration such that it substantially fills the lumen of the vesseland the opening in the body is oriented proximally. Body fluid ispermitted to enter the enclosure through this proximally orientedopening and is permitted to pass through the distal length of the body.In so doing, the distal length of the body filters from the body fluidparticulate material entrained therein (assuming, of course, that thereis any such particulate material of an appropriate size). The proximallength of the body is drawn within the lumen of the catheter, therebyeffectively closing the proximally oriented opening within the retrievalsheath to retain said particulate material within the enclosure.

Further refinements of this method are envisioned. For example, in oneembodiment, the filter has a narrow proximal end which is smaller thanthe lumen of the catheter. In drawing the proximal length of the filterwithin the catheter, this narrow proximal end may be introduced into thedistal end of the catheter's lumen. The filter may then be retracteduntil the internal surface of the catheter engages the body of thefilter distally of the opening to effectively create a particulate sealtherebetween.

As noted above, the present invention also encompasses a device wellsuited for use in such procedures. In one embodiment, such a devicecomprises a collapsible filter system including a mandrel and a filter.The mandrel has proximal and distal ends and the filter is carried alongthe mandrel between these ends. The filter has a radially expandablebody having proximal and distal ends of its own. The body is formed of aporous, resilient fabric having pores therein through which a body fluidmay pass, but which are small enough to restrict passage of particulatematerial over a certain, predetermined size entrained in the body fluid.A proximally oriented hole passes through the fabric along a proximallength of the filter's body. This hole is spaced distally of theproximal end of the body and being at least about five times the size ofsaid pores.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medical filter in accordance with oneembodiment of the present invention;

FIG. 2 is a side elevation view of the filter of FIG. 1;

FIG. 3 is a cross sectional view of the medical filter of claim 1, takenalong line 3-3 of FIG. 2;

FIG. 4 is a schematic side view in partial cross section illustrating afilter of an alternative embodiment of the invention in a radiallyreduced configuration within a catheter;

FIG. 5 is a schematic side view illustrating the filter of FIG. 4deployed in a vessel in a patient's body;

FIG. 6 is a schematic side view of the filter of FIGS. 4 and 5 withcollected particulate material trapped within the filter;

FIG. 7 is a schematic side view of the filter of FIGS. 4-6 drawn farenough into the catheter to effectively close the proximally orientedopening within the catheter; and

FIG. 8 is a schematic side view of the filter of FIGS. 4-7 withdrawncompletely within the lumen of the catheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1-3 illustrate a filter system 10 in accordance with oneembodiment of the invention. This filter system can be used in anychannel in a patient's body, including blood vessels, the urinary tractor biliary tract and airways. This filter system 10 is optimallydesigned to be deployed in a patient's vessel in a minimally invasiveprocedure, such as by introducing the filter system into a blood vesselthrough a catheter (as described in greater detail below).

The filter system 10 of the invention generally includes a mandrel 20and a filter 50. Conceptually, the mandrel 20 can be thought of ashaving a primary function of positioning and controlling the deploymentof the filter 50 while the filter can be considered the primarytherapeutic or functional element of the system 10.

The mandrel 20 should be fairly flexible to allow the device to bedeployed in a curving body passageway without kinking or otherwiseinhibiting suitable deployment of the filter 50. While the mandrel canbe formed of any material having any dimension suitable for the task forwhich the filter system 10 is to be employed, in most circumstances, themandrel 20 will comprise an elongate metal wire. In one particularlypreferred embodiment, the mandrel 20 is formed of nitinol, a roughlystoichiometric alloy of nickel and titanium having excellent“superelastic” properties. The use of nitinol in medical guidewires andrelated applications is well known in the art and need not be discussedin detail here. If so desired, the distal-most length of the mandrel mayinclude a flexible helically wound coil 22 extending thereover. The useof such helical coils to enhance flexibility of the distal tip is wellknown in the guidewire art.

The mandrel 20 shown in FIGS. 1-3 has an enlarged diameter stop 40attached thereto. The stop 40 is spaced proximally from the distal tip25 of the mandrel 20. Desirably, the stop 40 is spaced proximally of theproximal end of the helical coil 22 of the mandrel. This permits thedistal slider 60 of the filter 50 to slide relatively freely andunencumbered along the length of the mandrel distally of the stop.

The stop 40 can be formed of any desired material and can be attached tothe mandrel 20 in any desired fashion. The stop should be attached tothe mandrel relatively securely, though, as the stop will be used tourge the filter 50 within the lumen of the vessel in which the system 10is to be deployed. As an example, the stop 40 may comprise a standardradiopaque marker band which has been securely crimped on the mandrel 20and/or attached to the mandrel using an adhesive or solder. The preciselength and shape of the stop 40 is not critical. The drawings illustratethe stop 40 as a relatively short cylindrical body attached about thecircumference of the mandrel. However, the stop 40 may have a morebulbous shape and could, in theory, even be formed integrally with themandrel.

The stop 40 effectively divides the mandrel into distal and proximallengths. The distal length 30 of the mandrel can be thought of as thatlength which extends distally from the stop 40 to the distal tip 25 ofthe mandrel. Likewise, the proximal portion 35 of the mandrel 20 can bethought of as comprising the length of the mandrel extending proximallyfrom the stop 40 to the proximal end of the mandrel.

The filter 50 shown in FIGS. 1-3 has an elongate, generally tubular body52 which extends from a distal slider 60 proximally to a proximal slider65. The body 52 of the filter can be formed of any material suitable forthe application at hand. In many applications, e.g., filtering bloodwithin a patient's vasculature, the filter body 52 typically comprises alength of a braided tubular fabric. The use of a tubular braid ofnitinol to make medical devices is described in some detail inInternational Publication No. WO 96/01591, the teachings of which wereincorporated above by reference. Briefly speaking though, this processcan employ a tubular braid of a fabric comprising two sets of nitinolwires wrapped helically about a mandrel, with one set of wires beingwrapped spirally about the mandrel in one direction and the other setbeing wrapped in the other direction. This braid is then placed incontact with a molding surface of a molding element which defines theshape of the desired functional element. By heat treating the fabric incontact with the molding surface of the molding element, one can createa functional element having virtually any desired shape.

The body 52 of the filter 50 desirably is made of a fairly flexible,resilient material. In particular, the filter 52 desirably has aradially expanded configuration, e.g., the shape shown in FIGS. 1-3,which the device will tend to resiliently assume in the absence of anycountervailing biasing force. A body 52 formed of a nitinol tubularbraid which has been heat set into the desired shape should suit thispurpose well.

In the filter system 10 shown in FIGS. 1-3, the body 52 of the filter 50assumes a generally tubular shape having tapered proximal and distalends. The maximum outer diameter of the middle length of the body 52should be sized to substantially fill the lumen of a vessel to ensurethat the filter will effectively preclude any emboli (or otherparticulate material which may be entrained in the patient'sbloodstream) from passing around the filter.

The body of the filter includes a distal length 53 and a proximal length54, each of which tapers from the middle of the body's length to theirrespective ends. In particular, the distal length 53 tapers distallytoward a narrow distal end adjacent the distal slider 60 while theproximal length 54 of the filter body tapers toward its proximal endadjacent the proximal slider 65. The rate of this tapering can be variedas desired. While FIGS. 1-3 illustrate a fairly gradual taper, thechange in diameter may be more abrupt. The filter body 52 of FIGS. 1-3is also fairly symmetrical, with the tapers of the proximal and distallengths being about the same. In some circumstances it may beadvantageous to have the two lengths taper differently, e.g. where theproximal length tapers more gradually while the distal length changesdiameter more abruptly.

The proximal length 54 of the filter body has at least one proximallyoriented opening 56 therein. This opening passes through the flexible,resilient fabric of which the body 52 desirably is formed. The fabrichas pores therein which allow fluids to pass therethrough, but the poresare small enough to prevent passage of particles larger than apredetermined size. If the body is formed of a metallic tubular braid asmentioned above, the maximum sizes of these pores can be controlled byadjusting the number of wires in the braid and the pick and pitch of thebraid. For example, if the filter 50 is to be employed as a vascularfilter, a pore size of 20-1500 microns is desirable. If such a filterbody has a maximum diameter of about 4 mm, it may be formed of 48 wireseach having a diameter of about 0.002 inches (about 50 microns) and apick rate of about 90 per inch (about 35 per centimer).

The size of the proximally oriented opening 56 should be sufficient topermit body fluid with particulate material entrained therein to enterthe enclosure within the body 52 of the filter. At a minimum, it isexpected that the opening will be at least five times the maximum poresize of the fabric of which the body is formed, with an opening of atleast ten times the maximum pore size being preferred.

The opening 56 can be formed in any suitable fashion. If the filter isformed from a preformed flat sheet of fabric wrapped into the desiredshape, the opening can be cut through the fabric before the fabric isshaped into the filter body. If the body 52 is formed of a tubularmetallic braid, it may instead be cut through the fabric after the braidis heat set in the desired shape.

In one particularly preferred method of forming the filter (which methodcomprises another embodiment of the invention), a tubular metal braid isprovided. The distal and proximal sliders 60, 65 are attached to thebraid a suitable distance from one another. The braid is trimmed at thedistal end of the distal slider 60 and at the proximal end of theproximal slider 65. A forming mandrel (not shown) is passed between thewire strands of the braid and positioned within the tubular braid.

The forming mandrel has an external molding surface which generallycoincides with the desired shape of the filter body. The forming mandrelmay have a larger diameter than the inner diameter of the tubular braidand the braid may be drawn down against the forming mandrel by applyingaxial tension to the braid. This structure may be heated at an elevatedtemperature to heat-set the filter body 52 in this shape and the formingmandrel may be removed.

The forming mandrel includes a proximal projection having a peripherythe size and shape of the desired proximal opening 56. This projectionextends through the wire mesh of the tubular braid during heattreatment, forcing the wire strands to extend about the periphery of theprojection. As a consequence of the heat treatment, when the formingmandrel is removed, the wires will retain the proximal opening withoutrequiring cutting the fabric.

In FIGS. 1-3, the filter 50 is shown as having a single opening 56extending over only one side of the proximal length 54 of the filterbody (i.e., above the mandrel 20 in FIG. 2). To increase the percentageof body fluid which passes into the enclosure of the filter body, thenumber of openings or the shape of the opening(s) can be adjusted tomaximize the cross sectional area of the vessel covered by the openings.For example, a plurality of openings can be spaced equiangularly aboutthe proximal length 54, such as three openings arranged about 120degrees from one another.

The opening 56 in FIGS. 1-3 is generally elliptical with a major axisextending generally in a plane which contains the axis of the mandrel20. If one were to increase coverage of the opening 56 by adjusting itsshape, the strength of the filter and its connection to the proximalslider 65 should not be compromised. One way to accomplish this is tooffset the filter 50 with respect to the mandrel 20. In FIGS. 1-3, thebody 52 of the filter is generally symmetrical about a centrallongitudinal axis and this axis generally coincides with the axis of themandrel. One could instead make the filter asymmetrical, with the axisof the mandrel 20 spaced radially outwardly from the central axis of thebody 52. In such a design, the mandrel could extend adjacent to one sideof the body and the opposite side of the body would extend farther fromthe mandrel. By positioning the opening 56 on the larger side of thebody, the opening can be made larger and cover more of the crosssectional area of the vessel in which the filter is deployed.

While the opening 56 can extend up to or even into the proximal slider65, in a preferred embodiment the opening 56 is spaced distally from theslider 65 and the proximal end of the body 52. This will enable a moresecure connection between the slider 65 and the body. The distal end ofthe opening desirably terminates proximally of the location where thefilter body has its maximum diameter. This will minimize the chance thatbody fluid could slip between the filter and the wall of the vessel inwhich the filter is deployed. This will also provide a more effectiveseal between the filter body 52 and the catheter in which it isretrieved. (Such retrieval is discussed below in connection with FIGS. 7and 8.)

The filter 50 is attached to or carried by the mandrel 20 by means of aproximal slider 65 attached to the body 52 adjacent its proximal end anda distal slider 60 attached adjacent the distal end of the body 52. Thedistal slider 60 should be free to slide along at least a proximalportion of the distal length 30 of the mandrel while the proximal slider65 should be free to slide along at least a distal portion of theproximal length 35 of the mandrel. In use, the stop 40 of the mandreleffectively defines a limit on the range of motion of these sliders 60,65.

While each of the sliders 60, 65 should be slidable along its respectivelength of the mandrel, the sliders can take any desired shape. In theillustrated embodiments, each slider comprises a relatively thin ringwhich is carried about the mandrel. The thin ring can be attached to thebody 52 in any desired fashion, such as by crimping or swaging thefabric of the body between two layers of the ring or soldering, weldingor otherwise adhering the fabric to the ring.

The stop 40 of the mandrel is positioned within the body 52 of thefilter and is not exerting any biasing force on either of the sliders60, 65. In this configuration, the mandrel 20 can be moved proximallyand distally with respect to the filter 50 without substantiallyaffecting the shape or position of the filter. The limits of this rangeof free movement of the mandrel with respect to the filter are generallydefined by the relationship between the stop 40 and the sliders 60, 65.In particular, the mandrel can be moved from a distal position whereinthe stop 40 abuts but does not exert any force on the distal slider 60and a proximal position wherein the stop 40 abuts, but does not exertany significant force on, the proximal slider 65. This allows the filter50 (or any other functional element which is carried by the mandrel) tobe fairly precisely positioned within a patient's vessel and retain thatposition even if the guidewire is moved slightly during use. This can beadvantageous in circumstances where other devices are exchanged over theguidewire (e.g., during angioplasty and atherectomy procedures).

The inner diameter of the generally annular collars defining the sliders60, 65 is desirably larger than the outer diameter of the mandrel, butshould be smaller than the outer diameter of the stop 40. In thisfashion, the stop serves as an effective limit on proximal movement ofthe distal slider 60 and distal movement of the proximal slider 65.Apart from this relationship with the slider 40 and the fact that bothsliders are indirectly linked to one another by the body 52 of thefitter, the proximal and distal sliders are slidable along the mandrelessentially independently of one another.

When the mandrel 20 is urged distally (to the left in FIGS. 2 and 3)against the distal slider 60, the stop will exert a distal biasing forceagainst the distal end of the body 52 of the filter. In theory, if thefilter were used in a frictionless environment, the filter would travelwith the mandrel without any appreciable alteration in the shape of thebody 52. In most clinical applications, though, this is not the case.Instead, there is typically some force restraining completely freemovement of the filter within the channel of the patient's body.Typically (and as suggested in FIGS. 5 and 6, for example), the body 52of the filter will resiliently expand into physical contact with theinterior surface of the vessel within which it is deployed. This contactwith the vessel wall will tend to hold the filter 50 in place as thestop of the mandrel slides proximally and distally between the twosliders 60, 65. When the mandrel is urged distally until it exerts adistal force against the distal slider 60, this force will tend toaxially elongate the body 52.

Resilient tubular braids tend to assume a radially reduced profile uponaxial elongation. (This property and some of its implications arediscussed in International Publication No. WO 96/01591, mentionedpreviously.) As a consequence, when the mandrel 20 is urged distally topush distally against the distal slider 60, this distal force actsagainst the restorative force of the resilient braid, which wouldotherwise bias the braid into its expanded configuration (FIGS. 1-3). Byovercoming this restorative force with a countervailing distal force,the body 52 will tend to both axially elongate and assume a radiallyreduced profile. This, in turn, reduces the force with which the bodyengages the wall of the vessel or catheter in which the filter ispositioned and reduces friction between the filter 50 and the vessel orcatheter. Hence, urging the mandrel distally to move the filter 50distally will, at the same time, reduce friction between the filter andthe vessel wall to further facilitate advancement of the filter alongthe vessel's lumen. This requires less force to push the filterdistally, enabling the mandrel to be smaller and reducing the outerdiameter of the collapsed device, making deployment in smaller vesselsfeasible. In addition, the reduced friction between the filter and thevessel wall limits damage to the intima of the vessel, permitting thefilter to be deployed and moved with a minimum of trauma.

When the mandrel is retracted proximally, the stop 40 of the mandrelwill abut against, and exert a proximal biasing force on, the proximalslider 65 of the filter 50. This proximal biasing force will act againstthe restorative force of the body 52 to axially elongate and radiallyreduce that body. This permits the device to be withdrawn proximallyalong the lumen of the vessel either for repositioning at a moreproximal location or for withdrawal from the patient's body at the endof the procedure.

In the embodiment of FIGS. 1-3, the proximal and distal sliders 60, 65are free to move relatively independently of one another, limitedprimarily by their indirect link to one another through the body 52 ofthe filter. For example, when the mandrel 20 is urged distally againstthe distal slider 60 (FIG. 4), the proximal slider will slide proximallyalong the proximal length 35 of the mandrel. Similarly, when the mandrelis withdrawn proximally to urge proximally against the proximal slider65, the distal slider will be free to drift distally along the distallength 30 of the mandrel. Ideally, there should be a sufficient distancebetween the distal shoulder of the stop 40 and the proximal end of thehelical coil 22 at the distal end of the mandrel.

FIGS. 4-8 schematically depict one method of the invention utilizing analternative filter design. Most of the elements of the filter 50′ inFIGS. 4-8 are essentially the same as like elements in FIGS. 1-3, so thesame reference numbers have been used for most elements in both sets ofdrawings. The primary differences between the filter 50′ of FIGS. 4-8and the filter 50 described above is that the stop 40 has been omittedin FIGS. 4-8 and the proximal slider 65′ has been secured to the mandrel20 at a fixed location. The distal slider 60 remains free to slide alongthe mandrel.

The body 52′ of the filter 50′ is shaped a little differently from thefilter body 52 of FIGS. 1-3. This difference is not crucial and does notyield significantly different properties. Instead, the differences inthe fully deployed shapes of the two filters 50, 50′ are intended tohighlight that the shape can vary without compromising the filter'sfunction.

FIG. 4 schematically illustrates the filter 50′ collapsed within thelumen of a catheter C. The body 52′ of the filter has been collapsedunder the biasing force of the catheter walls into an axially elongated,radially reduced configuration. This catheter and filter combination maybe advanced through a patient's body as a unit until a specifictreatment site has been reached, but this combined unit may be dificultto steer through a more tortuous path. For many applications (e.g.,deployment at a remote site within a patient's vasculature), thecatheter will first be positioned adjacent the treatment site. Only thenwill the filter system be inroduced into the distal end of the catheterC and urged along the catheter's lumen and the vessel V until the distalend 25 of the mandrel and the distal slider 65 are positioned adjacentthe distal end of the catheter, as shown in FIG. 4.

Regardless of how the system reaches the state illustrated in FIG. 4,once the catheter is in place the filter 50′ can be deployed out thedistal end of the catheter. In particular, the filter 50′ may be urgedout of the distal end of the catheter, e.g., by holding the catheter Cstill and urging the mandrel 20 distally or by holding the mandrel 20stationary and withdrawing the catheter C proximally.

Upon exiting the distal end of the catheter C, the flexible body 52 willresiliently expand radially outwardly, desirably until it engages thewall of the vessel V or, less desirably, is positioned adjacent to thevessel wall. (Such a configuration is shown in FIG. 5.) This will helpensure that all fluid passing along the vessel V will have to passthrough the filter body 52′.

A substantial portion (ideally, all or at least a vast majority) of thebody fluid in the vessel should pass through the proximally orientedopening 56 in the filter body. Since the opening is fairly large, it isanticipated that any particulate material entrained in the body fluidtravelling through the vessel will enter the interior of the filterthrough the opening 56. The pores in the distal length 53 of the filterbody are significantly smaller, though, so most oversized particles willbe trapped within the enclosure of the filter body. FIG. 6 schematicallydepicts such a situation, with a number of individual particles P beingshown trapped within the filter body. If the filter 50 or 50′ is to beused in a vascular procedure, the pores should be large enough to permitred blood cells to pass therethrough, but small enough to trap thrombior emboli above a certain predetermined size.

A wide variety of vascular filters are known in the art and the easewith which such filters can be deployed varies. One of the primarydistinguishing characteristics between these various filter designs isthe ease with which the filters can be withdrawn from or repositionedwithin the patient's body. For example, most commercially available venacava filters are provided with sharp barbs or other structures whichfirmly seat the devices in a wall of the vessel, but which effectivelypreclude retraction of the device. Temporary filters avoid suchtenacious attachments to the vessel wall, permitting them to beretracted or moved after initial deployment. As noted above, though, oneof the primary difficulties encountered in using such temporary filtersis the risk of dumping the captured particulate material back into thevessel from which it was filtered. Many designs require that thephysician first aspirate the particulate material or, in the case ofthrombi captured in vascular procedures, use drugs which help break downthe particles to clinically acceptable sizes.

International Publication No. WO 96/01591, mentioned previously,provides a particularly useful filter. This filter, which may begenerally dome-shaped and have a proximally-facing lip, enables aphysician to close the filter prior to retraction, keeping the capturedparticles within the filter during removal or repositioning.Unfortunately, this design is mechanically complex. In one embodimentdisclosed therein, the filter is provided with a drawstring which can beused to draw the proximal edge of the filter down toward the wire onwhich it is carried, minimizing the risk of losing the particles. Asecond design proposed in this reference employs a separately deployablecover which can be brought into sealing engagement with the filter.While this may further reduce the risk of dumping particles back intothe vessel, the increased mechanical complexity makes it difficult toprovide a highly reliable, cost-effective device.

The present invention provides an elegant solution to these difficultieswhich minimizes mechanical complexity and promises to provide veryeffective containment of filtered particles. FIG. 7 shows the filter 50′of FIGS. 4-6 partially retracted into the catheter C. If the filter isbeing used for only a short period of time, the catheter C may be thesame catheter used to initially deploy the filter in the vessel. If thefilter is to be left in place for a longer period of time, though, itmay be preferred to remove the deployment catheter (FIG. 4) from thepatient's body and later introduce a separate retrieval catheter byadvancing-the retrieval catheter along the mandrel 20.

The lumen of the retrieval catheter C in FIG. 7 has a diameter smallerthan the maximum cross-sectional dimension of the body's expandedconfiguration. The lumen is larger than the narrow proximal end of thefilter body 52′ adjacent the proximal slider 65′, though, and theillustrated filter body is spaced from the vessel wall about its entireperiphery. As a consequence, the distal tip of the catheter can bepositioned between the proximal end of the body 52′ and the wall of thevessel V before the catheter engages the body of the filter adjacent theslider. This can be done by holding the catheter in place andwithdrawing the mandrel proximally, by holding the mandrel stationaryand moving the catheter distally, or moving both the catheter and themandrel.

Once the proximal end of the body 52′ is introduced into the catheter'slumen, the rest of the body can be drawn into the lumen of the catheter.Again, the body can be drawn into the catheter by advancing the catheterdistally or retracing the filter proximally. At some point, the wall ofthe catheter C will engage the larger diameter body 52. Ideally, thelumen of the catheter is notably smaller than the deployed diameter ofthe filter body. As shown in FIG. 7, in this case the walls of thecatheter will exert a biasing force to urge the body toward the radiallyreduced configuration in which it was initially deployed (FIG. 4).

Perhaps more importantly, though, the internal surface of the catheterengages the body of the filter distally of the filter's proximallyoriented opening 56. While the opening may still be open to the lumen ofthe catheter, the engagement between the filer body and the catheterwall distally of the opening effectively creates a particulate sealtherebetween. As a consequence, simply by advancing the catheter C withrespect to the filter 50′, one can seal within the combined catheter andfilter all of the captured particles above the predetermined minimumsize. This combination can then be moved as a unit either to remove itfrom or reposition it within the patient's body with minimal risk oflosing any of the captured particles.

If the filter is to be completely withdrawn from the vessel, it ispreferred that the filter body 52′ be completely withdrawn into thelumen of the catheter (as shown in FIG. 8) rather than leaving a distalsection of the filter extending out of the catheter (as shown in FIG.7). This will reduce friction against the vessel wall, making withdrawaleasier and reducing trauma to the intima of the vessel.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications may be made therein without departing from the spirit ofthe invention and the scope of the appended claims.

1. Apparatus for filtering emboli from blood flowing through a vessel,the apparatus comprising: a guide wire having a distal region and a stopon the distal region; a capture ring disposed for translation on theguide wire, the stop limiting translation of the capture ring in adistal direction; and a filter sac connected to the capture ring,wherein, when the filter sac is deployed in the vessel, rotation ordistal translation of the guide wire relative to the capture ring doesnot displace the filter sac, but retraction of the guide wire in aproximal direction causes the stop to abut against the capture ring. 2.Apparatus for filtering emboli from blood flowing through a vessel, theapparatus comprising: a guide wire having a first portion having a firstdiameter and a distal region having a second diameter greater than thefirst diameter; and a filter element having a capture ring disposed fortranslation on the first portion, the capture ring having an aperturegreater than the first diameter but smaller than the second diameter,wherein rotation or distal translation of the guide wire relative to thecapture ring does not displace the filter element.
 3. The apparatus ofclaim 2 wherein the filter element comprises an expandable sac.
 4. Theapparatus of claim 2 wherein the guide wire further comprises a flangedisposed on the distal region having a diameter larger than the diameterof the aperture in the capture ring.
 5. A method of filtering embolifrom blood flowing through a vessel, the method comprising: providing aguide wire having a distal region including a stop, and a filter elementhaving a capture ring disposed for translation on the guide wireproximal of the stop; transluminally inserting the guide wire and filterelement into a vessel; deploying the filter element to engage a wall ofthe vessel, the filter element filtering emboli out of blood flowingthrough the vessel; advancing a treatment device along the guide wire totreat a portion of the vessel proximal to the location of the filterelement, rotation or distal translation of the guide wire relative tothe filter element imparted by the treatment device not displacing thefilter element.
 6. The method of claim 5 further comprising: providing adelivery sheath; and compressing the filter element to a contractedstate to insert the filter element within the delivery sheath.
 7. Themethod of claim 5 wherein the filter element comprises an expandablesac, and deploying the filter element comprises expanding the expandablesac so that a perimeter of the expandable sac contacts the wall of thevessel.
 8. Apparatus for filtering emboli from blood flowing through avessel, the apparatus comprising: a guide wire having a distal regionand a stop on the distal region; a ring disposed for translation on theguide wire, the stop limiting translation of the ring in a distaldirection; and a filter connected to the ring, wherein, when the filteris deployed in the vessel, rotation of the guide wire relative to thering does not displace the filter, but retraction of the guide wire in aproximal direction causes the stop to abut against the ring. 9.Apparatus for filtering emboli from blood flowing through a vessel, theapparatus comprising: a guide wire having a first portion having a firstdiameter and a distal region having a second diameter greater than thefirst diameter; and a filter element having a ring disposed fortranslation on the first portion, the ring having an aperture greaterthan the first diameter but smaller than the second diameter, whereinrotation or distal translation of the guide wire relative to the ringdoes not displace the filter element.
 10. The apparatus of claim 9wherein the filter element comprises an expandable sac.
 11. A method offiltering emboli from blood flowing through a vessel, the methodcomprising: providing a guide wire having a distal region including astop, and a filter element having a ring disposed for translation on theguide wire proximal of the stop; transluminally inserting the guide wireand filter element into a vessel; deploying the filter element to engagea wall of the vessel, the filter element filtering emboli out of bloodflowing through the vessel; advancing a treatment device along the guidewire to treat a portion of the vessel proximal to the location of thefilter element, rotation of the guide wire relative to the filterelement imparted by the treatment device not displacing the filterelement.
 12. The method of claim 11 further comprising: providing adelivery sheath; and compressing the filter element to a contractedstate to insert the filter element within the delivery sheath.
 13. Themethod of claim 11 wherein the filter element comprises an expandablesac, and deploying the filter element comprises expanding the expandablesac so that a perimeter of the expandable sac contacts the wall of thevessel.
 14. Apparatus for filtering emboli from blood flowing through avessel, the apparatus comprising: a guide wire having a distal regionand a stop on the distal region; a capture ring disposed for translationon the guide wire, the stop limiting translation of the capture ring ina distal direction; and a self-expanding filter sac connected to thecapture ring; wherein, when the filter sac is deployed in the vessel,rotation or distal translation of the guide wire relative to the capturering does not displace the filter sac, but retraction of the guide wirein a proximal direction causes the stop to abut against the capturering.
 15. Apparatus for filtering emboli from blood flowing through avessel, the apparatus comprising: a guide wire having a first portionhaving a first diameter and a distal region having a second diametergreater than the first diameter; and a self-expanding filter elementhaving a capture ring disposed for translation on the first portion, thecapture ring having an aperture greater than the first diameter butsmaller than the second diameter, wherein rotation or distal translationof the guide wire relative to the capture ring does not displace thefilter element.
 16. The apparatus of claim 15 wherein the filter elementcomprises an expandable sac.
 17. The apparatus of claim 15 wherein theguide wire further comprises a flange disposed on the distal regionhaving a diameter larger than the diameter of the aperture in thecapture ring.
 18. A method of filtering emboli from blood flowingthrough a vessel, the method comprising: providing a guide wire having adistal stop, and a filter element having a capture ring disposed fortranslation on the guide wire proximal of the stop; transluminallyinserting the guide wire and filter element into a vessel; deploying thefilter element to engage a wall of the vessel, the filter elementfiltering emboli out of blood flowing through the vessel; advancing atreatment device along the guide wire to treat a portion of the vesselproximal to the location of the filter element, rotation or distaltranslation of the guide wire relative to the filter element notdisplacing the filter element.
 19. A method of filtering emboli fromblood flowing through a vessel, the method comprising: providing a guidewire having a distal stop, and a filter element having a ring disposedfor translation on the guide wire proximal of the stop; transluminallyinserting the guide wire and filter element into a vessel; deploying thefilter element to engage a wall of the vessel, the filter elementfiltering emboli out of blood flowing through the vessel; advancing atreatment device along the guide wire to treat a portion of the vesselproximal to the location of the filter element, rotation of the guidewire relative to the filter element not displacing the filter element.